Indication: CONTRAVE® (naltrexone HCI/bupropion HCl) is a prescription weight-loss medicine that may help adults with obesity (BMI greater than or equal to 30 kg/m2), or who are overweight (BMI greater than or equal to 27 kg/m2) with at least one weight-related medical condition, lose weight and keep the weight off. CONTRAVE should be used along with diet and exercise.

Limitations of Use: The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

How CONTRAVE® Works*

*The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood.

The Science Behind CONTRAVE®

CONTRAVE® is a prescription-only, FDA-approved weight-loss pill believed to work on two areas of your brain—the hunger center and the reward system—to reduce hunger and help control cravings.1 CONTRAVE contains two medicines, bupropion and naltrexone. These well-known drugs have been prescribed separately for years—bupropion for depression and smoking cessation, and naltrexone for alcohol and opioid dependence.2

1The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood.2The individual components of CONTRAVE are not approved for weight loss. CONTRAVE is not approved to treat depression or other mental illnesses, alcohol or opioid dependency, or to help people quit smoking.

The mesolimbic reward system to help control cravings

The hypothalamus (hunger center) to reduce hunger

CONTRAVE has a well-studied safety and tolerability profile. Three long-term (56 weeks) studies have shown that patients who add CONTRAVE lose approximately 2 to 4 times more weight than with diet and exercise alone.3 In one study, patients who also participated in an intensive diet and exercise program and remained on CONTRAVE for a full year, lost 25 pounds on average.

3Across three 56-week studies, 46% of patients on CONTRAVE lost 5% or more body weight (vs 23% of patients on placebo). Results may vary.

Across three studies, patients who added CONTRAVE for a full year:

Lost Approximately

2-4x

more weight on average than with diet and exercise alone3

In one study, patients who took CONTRAVE for a full year and participated in intensive diet and exercise programs:

Did you knowthat cravings are one of the main reasons diets fail?

Learn more about the potential for long-term weight loss with CONTRAVE

CONTRAVE was studied for efficacy and safety in
several clinical trials that included thousands of patients.

In three long-term studies,

2,322 participants

were enrolled who were struggling
with obesity (BMI of 30 or greater) or were overweight (BMI of 27 or greater).

Those with a BMI between 27 and 29.9 had at least one weight-related medical condition, such as controlled hypertension, dyslipidemia, or diabetes. While some participants received CONTRAVE, others were randomly selected to receive a placebo. Everyone participated in lifestyle modification programs that included a reduced-calorie diet and regular physical activity.

After 56 weeks, across the three studies,

46%

of patients taking CONTRAVE lost5% or moreof their body weight with CONTRAVE

vs.

23%

of patients on placebo.

Study 1

In this 56-week study, patients taking CONTRAVE lost 5.4% of their body weight (on average) compared with the placebo group who lost 1.3% (on average) with diet and exercise alone.

Additionally, 42% of the CONTRAVE users lost at least 5% of their total body weight (while 17% of the placebo group lost at least 5% of their total body weight with diet and exercise).

For participants who remained on CONTRAVE for the whole study, average weight loss was 8.1% or approximately 18 pounds, which was 4 times more weight than participants taking placebo.

COR-1 study

Study 2

In this 56-week study, patients participated in an intensive diet and exercise program, including group visits. At 56 weeks, patients taking CONTRAVE lost 8.1% (on average) of their total body weight compared with a body weight loss of 4.9% (on average) for the placebo group.

Additionally, 57% of those who took CONTRAVE lost at least 5% of their total body weight (while 43% of those on placebo lost at least 5% body weight with diet and exercise alone).

For participants who remained on CONTRAVE for the whole study, average weight loss was 11.5% or approximately 25 pounds.

COR-BMOD study

Study 3

For people with type 2 diabetes, CONTRAVE has the potential to provide sustainable weight loss and this weight loss may also lower A1C levels. In this study, patients taking CONTRAVE lost 3.7% of their body weight (on average) compared with the placebo group who lost 1.7% (on average) with diet and exercise alone after 56 weeks.

Additionally, 36% of those who took CONTRAVE lost at least 5% of their total body weight (while 18% of the placebo group lost at least 5% of their total body weight with diet and exercise).

CONTRAVE users also had a reduction in HbA1c of 0.6% (compared with a reduction of 0.1% in the placebo group) at 56 weeks. (Keep in mind that CONTRAVE is not approved to treat diabetes.)

Taking CONTRAVE

If you’re new to CONTRAVE, it’s important to increase your dose slowly over time to help you adjust to the medication. Begin with one morning tablet during your first week, and then gradually work up to two tablets twice a day by week four. Remember to always take your CONTRAVE dose exactly as your doctor prescribes. Refer to this CONTRAVE dosing chart to help you stay on track, and know that some people, like those with renal or hepatic impairment, or those taking other medications, may need to follow a different dosing schedule.

Dosing for most patients taking CONTRAVE

CONTRAVE may help patients make long-term changes to their eating behavior, lose weight, and keep it off. Across three long-term studies, patients taking CONTRAVE lost approximately 2-4x more weight than with diet and exercise alone. In one study, patients who stayed on CONTRAVE for a full year and participated in intensive behavior modification lost 25 pounds on average.

For people who started with a BMI 30 to 35, more than 70% of those who saw results at Week 16 and remained on treatment for 56 weeks were able to move into a healthier, non-obese category (BMI 29.9 or less) after 1 year on CONTRAVE*.

If you have not lost at least 5% of your body weight after 16 weeks of taking CONTRAVE, your healthcare provider might tell you to stop taking it. CONTRAVE does not work for everyone in the same way.

*Nalpropion data on file

CONTRAVE was studied for efficacy and safety in numerous clinical trials that included thousands of patients.

In general, it is recommended you drink plenty of water when taking CONTRAVE. Some people taking CONTRAVE experience nausea as they increase their dose. If you experience nausea, you may also want to eat a small amount of dry toast with CONTRAVE. For most people, this symptom went away within the first four weeks of taking CONTRAVE. If symptoms do not improve, please consult with your doctor who may also recommend an over-the-counter anti-nausea medication for you.

Other common side effects include constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. Call your doctor if you experience side effects while taking CONTRAVE that bother you or don’t go away while taking CONTRAVE.

Be careful not to take CONTRAVE with high-fat meals, and also avoid drinking a lot of alcohol. Be sure to tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. This is important because CONTRAVE may affect the way other medications work, especially opioid medicines or medicines to help stop taking opioids.

Real Life Success Stories

One of the ingredients in CONTRAVE, bupropion, may increase the risk of suicidal thinking in children, adolescents, and young adults. CONTRAVE patients should be monitored for suicidal thoughts and behaviors. In patients taking bupropion for smoking cessation, serious neuropsychiatric adverse events have been reported. CONTRAVE is not approved for use in children under the age of 18.

Stop taking CONTRAVE and call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.

Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, APLENZIN or ZYBAN; have or have had an eating disorder; are dependent on opioid pain medicines or use medicines to help stop taking opioids such as methadone or buprenorphine, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking; are allergic to any of the ingredients in CONTRAVE; or are pregnant or planning to become pregnant.

Before taking CONTRAVE, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider says it is okay.

Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant; or breastfeeding.

CONTRAVE may cause serious side effects, including:

Seizures. There is a risk of having a seizure when you take CONTRAVE. If you have a seizure, stop taking CONTRAVE, tell your healthcare provider right away.

Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone.

Sudden opioid withdrawal. Do not use any type of opioid for at least 7 to 10 days before starting CONTRAVE.

Severe allergic reactions. Stop taking CONTRAVE and get medical help immediately if you have any signs and symptoms of severe allergic reactions: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.

Increases in blood pressure or heart rate.

Liver damage or hepatitis. Stop taking CONTRAVE if you have any symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness.

Manic episodes.

Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye.

Increased risk of low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas).

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea.

These are not all the possible side effects of CONTRAVE. Tell your healthcare provider about any side effect that bothers you or does not go away.

Use of CONTRAVE

CONTRAVE is a prescription weight-loss medicine that may help some adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), or adults with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off.

CONTRAVE should be used with a reduced-calorie diet and increased physical activity

It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke

It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products

CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

One of the ingredients in CONTRAVE, bupropion, may increase the risk of suicidal thinking in children, adolescents, and young adults. CONTRAVE patients should be monitored for suicidal thoughts and behaviors. In patients taking bupropion for smoking cessation, serious neuropsychiatric adverse events have been reported. CONTRAVE is not approved for use in children under the age of 18.

Stop taking CONTRAVE and call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.

Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, APLENZIN or ZYBAN; have or have had an eating disorder; are dependent on opioid pain medicines or use medicines to help stop taking opioids such as methadone or buprenorphine, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking; are allergic to any of the ingredients in CONTRAVE; or are pregnant or planning to become pregnant.

Before taking CONTRAVE, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider says it is okay.

Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant; or breastfeeding.

CONTRAVE may cause serious side effects, including:

Seizures. There is a risk of having a seizure when you take CONTRAVE. If you have a seizure, stop taking CONTRAVE, tell your healthcare provider right away.

Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone.

Sudden opioid withdrawal. Do not use any type of opioid for at least 7 to 10 days before starting CONTRAVE.

Severe allergic reactions. Stop taking CONTRAVE and get medical help immediately if you have any signs and symptoms of severe allergic reactions: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.

Increases in blood pressure or heart rate.

Liver damage or hepatitis. Stop taking CONTRAVE if you have any symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness.

Manic episodes.

Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye.

Increased risk of low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas).

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea.

These are not all the possible side effects of CONTRAVE. Tell your healthcare provider about any side effect that bothers you or does not go away.

Use of CONTRAVE

CONTRAVE is a prescription weight-loss medicine that may help some adults with a body mass index (BMI) of 30 kg/m2 or greater (obese), or adults with a BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off.

CONTRAVE should be used with a reduced-calorie diet and increased physical activity

It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke

It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products

CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation).

CONTRAVE® is a registered trademark of Nalpropion Pharmaceuticals, Inc.

All other trademarks registered or otherwise are the property of their respective owners.

CON-0240-0018 10/2018

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